PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma

NCT05380635 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HPN-CTCL-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Keywords

CTCL; MF; Hypericin; HyBryte

Outcome Measures

Primary Outcomes (2)

• Electrocardiograms (ECG)

  Assess any ECG QT interval changes (defined as any occurrences of QT interval \>500 ms or changes in QT interval \>60 ms) during standard HyBryte photodynamic therapy.

  10 weeks

• Systemic Blood Levels

  Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.

  10 weeks

Secondary Outcomes (3)

• Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.

  10 weeks

• Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.

  10 weeks

• Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.

  10 weeks

Study Arms (1)

HyBryte (0.25 % Hypericin)

EXPERIMENTAL

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.

Drug: Hypericin

Interventions

Hypericin DRUG

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Also known as: HyBryte, SGX301

HyBryte (0.25 % Hypericin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA
• CTCL lesions covering ≥ 10% of their body surface area

You may not qualify if:

• History of allergy or hypersensitivity to any of the components of HyBryte
• Pregnancy or mothers who are breast-feeding
• Males and females not willing to use effective contraception
• Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
• Subjects whose condition is spontaneously improving
• Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment
• Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
• Subjects who have received electron beam irradiation within 3 months of enrollment
• Subjects with a history of significant systemic immunosuppression
• Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
• Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks

Sponsors & Collaborators

• Soligenix: lead

Study Sites (1)

Rochester Skin Lymphoma Medical Group

Fairport, New York, 14450, United States

Location

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

hypericin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Richard Straube, MD/Chief Medical Officer
• Organization: Soligenix, Inc.

rstraube@soligenix.com

609-538-8200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: May 9, 2022
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: June 7, 2023
• Results First Posted: June 7, 2023

Record last verified: 2023-05

Locations

US (1)